Model Number 500AVHCT |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Per the user facility's biomedical technician, the issue occurred about two weeks before it was reported.The inaccurate values were for partial pressure of carbon dioxide (pco2).
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Event Description
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It was reported that prior to the use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) values were inaccurate.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint could not be confirmed.During laboratory analysis, the product surveillance technician (pst) observed that the on-screen values could be adjusted to sample values throughout the evaluation.A sample 540 calibration was completed successfully.The monitor operated as intended throughout the evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Event Description
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Per clinical review: multiple diligence attempts were unsuccessful in obtaining additional clinical information.The details available are that the values were off from what was expected when the monitor was being used during an extracorporeal membrane oxygenation (ecmo) procedure.
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Manufacturer Narrative
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H3: 81 - evaluation is in progress, but not yet concluded.
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Search Alerts/Recalls
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